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Novartis Gets FDA Fast-Track Approval for Fabhalta in IgA Nephropathy

Novartis announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Fabhalta (iptacopan), a first-in-class complement inhibitor for the reduction...

Diality’s Moda-flx Hemodialysis System Wins FDA 510(k) Clearance

Diality, a medical device company developing a smart, flexible hemodialysis platform, announced that it has secured 510(k) clearance from the U.S. Food & Drug...

Advanced Sterilization Products and PENTAX Get FDA Nod for Duodenoscope Sterilization Cycle

Advanced Sterilization Products (ASP), a division of Fortive, in collaboration with PENTAX Medical, a division of HOYA, proudly announces the FDA clearance of the...

Life Spine Announces FDA 510(k) Clearance for the ARx SAI Spinal Fixation System

Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced  that it has...

Vertex Announces FDA Acceptance of New Drug Application for Suzetrigine for the Treatment of Moderate-to-Severe Acute Pain

Vertex Pharmaceuticals Incorporated announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) submission for suzetrigine, an investigational, oral,...
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